← Back to catalogue
IMMULITE® Systems ATA Calibration Verification Material Anti-TPO Ab
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- IMMULITE® Systems ATA Calibration Verification Material Anti-TPO Ab FDA UDI
- Generic Name
- Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control FDA UDI
- Device Name
- Anti-TPO CVM - IMMULITE - CONS FDA UDI
- Model / Reference
- 10373708 FDA UDI
- Description
- Anti-TPO CVM - IMMULITE - CONS FDA UDI
Identifiers
- Catalog Number
- LTOCVM FDA UDI
- Primary DI / UDI-DI
- 00630414971407 FDA UDI
- 510(k) Number
- K132391 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control
IMMULITE® Systems ATA Calibration Verification Material Anti-TPO Ab by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control.
- ADVIA Centaur® aTPO MCM — Siemens Healthcare Diagnostics · Class II
- Atellica IM aTPO MCM — Siemens Healthcare Diagnostics · Class I
- AccuTrak — LGC Clinical Diagnostics, Inc. · Class I
- ADVIA Centaur® Systems QC anti-TPO 1, 2 — Siemens Healthcare Diagnostics · Class II
- Atellica IM aTPO QC — Siemens Healthcare Diagnostics · Class II
- IMMULITE® 2000 Systems Anti-TPO CVM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI dfa9e69d-267c-44e1-bdc5-b023cc8bd592 37 fields · synced May 31, 2026